Neos Therapeutics® is a privately owned drug delivery and contract manufacturing company serving prescription pharmaceutical and consumer healthcare markets. Neos’ proprietary drug delivery technology platform is clinically proven. Our operating model is to develop prescription and OTC products working in partnership with healthcare companies. The Neos technology enables creation of innovative dosage forms, notably controlled release (CR) liquids and CR orally disintegrating tablets (ODTs). Our expertise, technology and full service contract manufacturing spans the range of oral drug dosage forms from conventional tablets and capsules to the truly unique CR liquids and CR ODTs.
The Laboratory Manager plans and implements the laboratory policies, procedures, and services for the Quality Control Laboratory. Ensures efficient and effective departmental operations, including department quality control and site quality compliance adherence.
Essential Job Functions
- Responsible for all QC sampling schedules and testing; ensure data and lab reports are being generated from the lab in a timely, accurate and methodical manner.
- Provide oversight for all QC laboratory operations and testing to approve/release all finished product, intermediates, stability and raw materials tested in the laboratory.
- Coordinate the stability program.
- Manage specification review process.
- Responsible for the review and approval of atypical data, out-of-specification (OOS) and out-of-trend (OOT) investigations.
- Oversee equipment lab calibration program.
- Develop and implement laboratory documents (SOPs, DOPs, Specifications, Protocols, Reports, etc…)
- Determine departmental metrics and monitor lab performance; present information in Quarterly Management Review meetings.
- Responsible for short and long term goals of QC Laboratory efforts in support of IND, NDA, ANDA, clinical efforts and commercial product supply and program-driven milestones.
- Responsible for the timely hiring, training and development of qualified staff to ensure effective testing, execution of roles and responsibilities, GMP compliance, and attainment of operational and development goals.
- Responsible for continuous improvement on an ongoing basis to proactively mitigate current and future risks to maintain an effective lab operation that supports business needs.
Knowledge and Skills Required
- Bachelor’s degree in science-related field. Masters Degree Preferred.
- 7+ years of pharmaceutical laboratory experience.
- 7+ years experience supervising and managing others.
- Proficient with HPLC, GC, FT-IR, particle site analysis, and other analytical equipment
- Technical writing experience.
No phone calls or recruiters please.